title: Multistate outbreak of Pseudomonas fluorescens bloodstream infection after exposure to contaminated heparinized saline flush prepared by a compounding pharmacy.
abstract: BACKGROUND
  Pharmaceutical compounding, the manipulation of ingredients to create a customized medication, is a widespread practice. In January 2005, the Centers for Disease Control and Prevention was notified of 4 cases of Pseudomonas fluorescens bacteremia that were traced to contaminated heparinized saline intravenous flush syringes prepared as a compounded medical product.
  
  
  METHODS
  We reviewed medical records of symptomatic patients with P. fluorescens-positive cultures of blood specimens or sections of explanted catheters, reviewed the production process of syringes, performed syringe cultures, compared isolates by pulsed-field gel electrophoresis (PFGE), and examined catheters by scanning electron microscopy.
  
  
  RESULTS
  We identified 80 patients in 6 states with P. fluorescens-positive cultures during December 2004-March 2006. Sixty-four patients (80%) had received a diagnosis of cancer. Seventy-four (99%) of 75 patients for whom information about catheter type was available had long-term indwelling catheters. Thirty-three (41%) of 80 cases were diagnosed 84-421 days after the patient's last potential exposure to a contaminated flush (delayed-onset cases). Compared with patients with early infection onset, more patients with delayed infection onset had venous ports (100% versus 50%; P <.001). By PFGE, clinical isolates from 50 (98%) of 51 patients were related to isolates cultured from unopened syringes. Scanning electron microscopy of explanted catheters revealed biofilms containing organisms morphologically consistent with P. fluorescens.
  
  
  CONCLUSIONS
  This outbreak underscores important challenges in ensuring the safety of compounded pharmaceuticals and demonstrates the potential for substantially delayed infections after exposures to contaminated infusates. Exposures to compounded products should be considered when investigating outbreaks. Patients exposed to contaminated infusates require careful follow-up, because infections can occur long after exposure.
authors.affiliation: Epidemic Intelligence Service, National Center for Preparedness, Detection and Control of Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
authors.forename: Mark D
authors.initials: MD
authors.lastname: Gershman
authors.forename: Donald J
authors.initials: DJ
authors.lastname: Kennedy
authors.forename: Judith
authors.initials: J
authors.lastname: Noble-Wang
authors.forename: Curi
authors.initials: C
authors.lastname: Kim
authors.forename: Jessica
authors.initials: J
authors.lastname: Gullion
authors.forename: Marilyn
authors.initials: M
authors.lastname: Kacica
authors.forename: Bette
authors.initials: B
authors.lastname: Jensen
authors.forename: Neil
authors.initials: N
authors.lastname: Pascoe
authors.forename: Lisa
authors.initials: L
authors.lastname: Saiman
authors.forename: Jean
authors.initials: J
authors.lastname: McHale
authors.forename: Melinda
authors.initials: M
authors.lastname: Wilkins
authors.forename: Dianna
authors.initials: D
authors.lastname: Schoonmaker-Bopp
authors.forename: Joshua
authors.initials: J
authors.lastname: Clayton
authors.forename: Matthew
authors.initials: M
authors.lastname: Arduino
authors.forename: Arjun
authors.initials: A
authors.lastname: Srinivasan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016470:Bacteremia / Q000453:epidemiology* / Q000382:microbiology; D015373:Bacterial Typing Techniques; D001769:Blood / Q000382:microbiology; D002408:Catheters, Indwelling / Q000009:adverse effects* / Q000382:microbiology; D002648:Child; D002675:Child, Preschool; D003428:Cross Infection / Q000453:epidemiology* / Q000382:microbiology; D004196:Disease Outbreaks; D016521:Electrophoresis, Gel, Pulsed-Field; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008855:Microscopy, Electron, Scanning; D008875:Middle Aged; D011552:Pseudomonas Infections / Q000453:epidemiology* / Q000382:microbiology; D011551:Pseudomonas fluorescens / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D012965:Sodium Chloride / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D012965:Sodium Chloride